Medline
Resusc,man,ped,mask,bag RES,MANO,3 Masks
8manufacturers in China registered for this device type
78catalogue numbers in this listing
Who Else Makes It
Concentrated in Fujian (4), Zhejiang (1), Guangdong (1). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| GaleMed (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 33 |
| Polymed (Xiamen) Plastic Industrial Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 17 |
| VR Medical Technology Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 13 |
| Ambu Limited | Xiang Yu F.T.Z., Xiamen | Fujian | Contract manufacturer | 11 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Laerdal Medical (Suzhou) Co., Ltd. | 215009 Suzhou Jiangsu Province | Repacker / relabeller | 12 | |
| Xiamen Compower Medical Tech. Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 9 |
Record
| Listed by | Medline Industries, Inc., United States |
|---|---|
| FDA product code | BTM |
| Device type | Ventilator, Emergency, Manual (Resuscitator) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5915 |
| Record published | 2021-10-29 |
| Record revised | 2022-04-05 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature -40 to 60 °C; Handling environment temperature -18 to 51 °C |
| Packaging | Case of 6, case of 12, case of 25, box of 10, case of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CPRM2216M3 | In distribution | |
| CPRM2216PM6 | In distribution | |
| CPRM2226FM | In distribution | |
| CPRM4426FPWT | In distribution | |
| CPRM3312FPM | In distribution | |
| CPRM3312FPM3 | In distribution | |
| CPRM2216FPMC | In distribution | |
| CPRM3322MG | In distribution | |
| CPRM3312FM123 | In distribution | |
| CPRM2216FPM3 | In distribution | |
| CPRM1116PD5 | In distribution | |
| CPRM3322M1 | In distribution | |
| CPRM4416P | In distribution | |
| CPRM4416PM | In distribution | |
| CPRM4416FM | In distribution | |
| CPRM1116T | In distribution | |
| CPRM3312FM | In distribution | |
| CPRM22162 | In distribution | |
| CPRM1116L | In distribution | |
| CPRM2216FM3 | In distribution | |
| CPRM1116FPWT | In distribution | |
| CPRM1126FPM | In distribution | |
| CPRM2226B | In distribution | |
| CPRM3312PMX | In distribution | |
| CPRM1126M | In distribution | |
| CPRM4426P | In distribution | |
| CPRM2216FM | In distribution | |
| CPRM1116C2 | In distribution | |
| CPRM1116PM | In distribution | |
| CPRM22163 | In distribution | |
| CPRM4426F | In distribution | |
| CPRM3312PM2 | In distribution | |
| CPRM4426FP | In distribution | |
| CPRM4416PWM | In distribution | |
| CPRM3322FM | In distribution | |
| CPRM4416FP | In distribution | |
| CPRM2226FPWM | In distribution | |
| CPRM4426 | In distribution | |
| CPRM4416FPM | In distribution | |
| CPRM2216PWM | In distribution | |
| CPRM2216PM | In distribution | |
| CPRM2226FPM | In distribution | |
| CPRM4416PD5 | In distribution | |
| CPRM1126FM | In distribution | |
| CPRM4416 | In distribution | |
| CPRM3312PM1 | In distribution | |
| CPRM3312M | In distribution | |
| CPRM2216B5 | In distribution | |
| CPRM2216P3M3 | In distribution | |
| CPRM1116PMT | In distribution | |
| CPRM1116FPM4 | In distribution | |
| CPRM1116PWM | In distribution | |
| CPRM3322M | In distribution | |
| CPRM3312PM3 | In distribution | |
| CPRM11163 | In distribution | |
| CPRM1116FPM | In distribution | |
| CPRM1116FM | In distribution | |
| CPRM1116B | In distribution | |
| CPRM3312P3M3 | In distribution | |
| CPRM2226M | In distribution | |
| CPRM4416FPM4 | In distribution | |
| CPRM3312M3 | In distribution | |
| CPRM1116M | In distribution | |
| CPRM2216M | In distribution | |
| CPRM4416F | In distribution | |
| CPRM33123 | In distribution | |
| CPRM1126FL | In distribution | |
| CPRM3312PWM | In distribution | |
| CPRM1126FPWM | In distribution | |
| CPRM1126FPWT | In distribution | |
| CPRM4416M | In distribution | |
| CPRM2216PKM | In distribution | |
| CPRM2216FPM | In distribution | |
| CPRM4426M | In distribution | |
| CPRM4426FPWM | In distribution | |
| CPRM4426FM | In distribution | |
| CPRM2216F | In distribution | |
| CPRM33122 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ventlab | Ventlab, LLC | 405 |
| CPR-2 Bag | Mercury Medical Enterprises, LLC | 231 |
| CPR Bag | Mercury Medical Enterprises, LLC | 187 |
| Vital Signs™ | Airlife, Inc. | 102 |
| Spur® II Pediatric ResuscitatorSingle Patient Use Resuscitator | Ambu A/S | 74 |
| Spur® II Adult ResuscitatorSingle Patient Use Resuscitator | Ambu A/S | 66 |
| Hudson RCI | Teleflex Medical LLC | 56 |
| Medline Industries, Inc. | Medline Industries, Inc. | 53 |
| Portex | ICU Medical, Inc | 45 |
| Spur® II Infant ResuscitatorSingle Patient Use Resuscitator | Ambu A/S | 45 |
| Curaplex® | Bound Tree Medical, LLC | 38 |
| Vital Signs | Carefusion | 31 |
Showing 12 of 342. All products under Ventilator, Emergency, Manual (Resuscitator)
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason |
|---|---|---|---|---|---|
| SunMed Group Holdings, LLC | UDI-DI | 2023-10-11 | Class II | Device Design | A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing. |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.